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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K023143
Device Name ECHO SOUNDER, ES-102EX
Applicant
Koven Technology, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Applicant Contact J. HARVEY KNAUSS
Correspondent
Koven Technology, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact J. HARVEY KNAUSS
Regulation Number884.2660
Classification Product Code
KNG  
Date Received09/20/2002
Decision Date 12/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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